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Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IBIO123
Placebo
Sponsored by
Immune Biosolutions Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring IBIO, IBIO123, Prophylaxis, Inhalation, monoclonal antibodies, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Are ≥18 years of age at the time of randomization Subject has a household contact with a confirmed COVID-19 cohabiting individual as subject. Initial diagnosis of the COVID-19 positive individual has been within 3 days of screening. COVID-19 positive result (PCR or Antigen) must have been performed by an accredited lab or medical professional. Current and uninterrupted household contacts were defined as family members or close relatives who had unprotected contact with the index case. Subject must have a negative result with the study provided rapid antigen test at baseline and be COVID-19 symptom free. Are men or non-pregnant women. Reproductive and Contraceptive agreements and guidance is provided in Appendix 2. Contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies. Understand and agree to comply with planned study procedures Agree to the collection of nasopharyngeal swabs The participant or legally authorized representative gives signed informed consent as described in Section 10.1.1.2 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: A positive COVID-19 result (PCR or antigen test) within 30 days of screening. Presence of typical COVID-19 symptoms which cannot be explained by another underlying condition (fever >38°C, Oxygen saturation (SpO2) below 93%, dyspnea, difficulty breathing, chills, ageusia, anosmia, cough, myalgia) in the past 48 hours prior to screening. Hypersensitivity to any component of IBIO123 Participants who have been previously administered IBIO123. Have received treatment with a SARS-CoV-2 specific monoclonal antibody Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. Are pregnant or breast feeding Are investigator site personnel directly affiliated with this study.

Sites / Locations

  • Jongaie Research
  • Central City Clinical Hospital of Chernivtsi City Council
  • City Clinical Hospital #1 of Ivano-Frankivsk City Council
  • Central C.H. of Ivano-Frankivsk
  • Volyn Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

IBIO123 10 mg

Matching Placebo

Outcomes

Primary Outcome Measures

Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 14
• Proportion of participants who had a laboratory-confirmed COVID-19 infection between baseline and Day 14

Secondary Outcome Measures

Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 7
Proportion of participants who had a laboratory-confirmed COVID-19 infection between baseline and Day 7
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 7
Proportion of participants who had a laboratory-confirmed asymptomatic COVID-19 infection between baseline and Day 7
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 14
Proportion of participants who had a laboratory-confirmed asymptomatic COVID-19 infection between baseline and Day 14
Characterize the effect of IBIO123 compared to placebo on overall participant clinical status
Proportion (percentage) of participants who experience these events by Day 14 Hospitalisation Mortality
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 related symptoms
Time to symptom onset Proportion of participants demonstrating symptom resolution on Days 7 & 14. Proportion of participants demonstrating Mild, Moderate and Severe symptoms between baseline to Day 7 and day 14
Characterize the effect of IBIO123 compared to placebo on safety and tolerability
Safety assessments such as adverse events (AEs) and Serious adverse events (SAEs)

Full Information

First Posted
December 3, 2022
Last Updated
May 18, 2023
Sponsor
Immune Biosolutions Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05639166
Brief Title
Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19
Official Title
A Phase 2, Randomized, Double-blind, Multicentre, Placebo-controlled Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2023 (Actual)
Primary Completion Date
May 16, 2023 (Actual)
Study Completion Date
May 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immune Biosolutions Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 2, randomized, double-blind, multicentre, placebo-controlled study in adults to assess the safety and efficacy of inhaled IBIO123, for post-exposure prophylaxis of COVID-19. This study aims to evaluate the efficacy and the safety of IBIO123 and the prophylaxis effect of IBIO123 in participants exposed to COVID-19 in the setting of current and uninterrupted household contacts.
Detailed Description
This is a randomized, double-blind, multicentre, placebo-controlled study eligible patients will be randomized in a 1:1 ratio to receive either 10mg of IBIO123 or matching vehicle (placebo). IBIO123 will be administered by inhalation via an Aerogen Ultra mesh nebulizer according to the manufacturer's recommendation. Patients will be followed up for a total period of 14 days after the administration of study intervention to detect an infection to SARS-CoV-2. This study will enroll a total of 140 participants (70 participants on IBIO123 & 70 participants on Placebo).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
IBIO, IBIO123, Prophylaxis, Inhalation, monoclonal antibodies, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
IBIO123 10 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Intervention Type
Biological
Intervention Name(s)
IBIO123
Intervention Description
IBIO123 10 mg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 14
Description
• Proportion of participants who had a laboratory-confirmed COVID-19 infection between baseline and Day 14
Time Frame
From Baseline to Day 14
Secondary Outcome Measure Information:
Title
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 7
Description
Proportion of participants who had a laboratory-confirmed COVID-19 infection between baseline and Day 7
Time Frame
From Baseline to Day 7
Title
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 7
Description
Proportion of participants who had a laboratory-confirmed asymptomatic COVID-19 infection between baseline and Day 7
Time Frame
From Baseline to Day 7
Title
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 14
Description
Proportion of participants who had a laboratory-confirmed asymptomatic COVID-19 infection between baseline and Day 14
Time Frame
From Baseline to Day 14
Title
Characterize the effect of IBIO123 compared to placebo on overall participant clinical status
Description
Proportion (percentage) of participants who experience these events by Day 14 Hospitalisation Mortality
Time Frame
From Baseline to Day 14
Title
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 related symptoms
Description
Time to symptom onset Proportion of participants demonstrating symptom resolution on Days 7 & 14. Proportion of participants demonstrating Mild, Moderate and Severe symptoms between baseline to Day 7 and day 14
Time Frame
From Baseline to Day 14
Title
Characterize the effect of IBIO123 compared to placebo on safety and tolerability
Description
Safety assessments such as adverse events (AEs) and Serious adverse events (SAEs)
Time Frame
From Baseline to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are ≥18 years of age at the time of randomization Subject has a household contact with a confirmed COVID-19 cohabiting individual as subject. Initial diagnosis of the COVID-19 positive individual has been within 3 days of screening. COVID-19 positive result (PCR or Antigen) must have been performed by an accredited lab or medical professional. Current and uninterrupted household contacts were defined as family members or close relatives who had unprotected contact with the index case. Subject must have a negative result with the study provided rapid antigen test at baseline and be COVID-19 symptom free. Are men or non-pregnant women. Reproductive and Contraceptive agreements and guidance is provided in Appendix 2. Contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies. Understand and agree to comply with planned study procedures Agree to the collection of nasopharyngeal swabs The participant or legally authorized representative gives signed informed consent as described in Section 10.1.1.2 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: A positive COVID-19 result (PCR or antigen test) within 30 days of screening. Presence of typical COVID-19 symptoms which cannot be explained by another underlying condition (fever >38°C, Oxygen saturation (SpO2) below 93%, dyspnea, difficulty breathing, chills, ageusia, anosmia, cough, myalgia) in the past 48 hours prior to screening. Hypersensitivity to any component of IBIO123 Participants who have been previously administered IBIO123. Have received treatment with a SARS-CoV-2 specific monoclonal antibody Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. Are pregnant or breast feeding Are investigator site personnel directly affiliated with this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Labbe, PhD
Organizational Affiliation
Immune Biosolutions
Official's Role
Study Director
Facility Information:
Facility Name
Jongaie Research
City
Pretoria West
State/Province
Pretoria
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Central City Clinical Hospital of Chernivtsi City Council
City
Chernivtsi
State/Province
Chernivetska
ZIP/Postal Code
58005
Country
Ukraine
Facility Name
City Clinical Hospital #1 of Ivano-Frankivsk City Council
City
Ivano-Frankivs'k
State/Province
Ivano-Frankivsk Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Central C.H. of Ivano-Frankivsk
City
Ivano-Frankivs'k
State/Province
Ivano-Frankivsk Oblast
ZIP/Postal Code
76025
Country
Ukraine
Facility Name
Volyn Regional Clinical Hospital
City
Luts'k
State/Province
Volyn Oblast
ZIP/Postal Code
43005
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19

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